Diclofenac tabs n / an kish.rastv. 50mg 20 pcs Hemofarm

$0.88

Diclofenac tabs n / an kish.rastv. 50mg 20 pcs Hemofarm

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Description

Composition
Active substance:
Diklofenak natriya 50 mg.
Excipients:
Lactose monohydrate – 46.6000 mg maize starch – 59.2000 mg, povidone-K30 – 10,0000 mg of sodium lauryl sulfate – 10.0000 mg Sodium carboxymethyl – 20.0000 mg colloidal silica – 3,0000 mg magnesium stearate – 1.2000 mg; sheath: methacrylic acid-ethyl acrylate copolymer – 4.1379 mg makrogol 6000 – 1.0345 mg, talk – 6.7241 mg of titanium dioxide, E 171 CI 77891 – 1.0345 mg, sunset yellow dye [E110] – 2, 0670 mg.
Description:
Round biconvex tablets, enteric coated orange, on fracture from white to almost white color.
Product form:
The tablets, enteric-coated tablets, 50 mg.
10 tablets in blisters (blister) from the PVC film and aluminum foil printed patent. 2 blisters (blister) together with instructions for use of the drug in a pile of cardboard.
Contraindications
Hypersensitivity to the active agent (including to other NSAIDs.) Or auxiliary components;
Full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history).;
Erosive and ulcerative changes of the gastric mucosa or duodenum 12, active gastrointestinal bleeding;
Inflammatory bowel disease (ulcerative colitis, Crohn’s disease) in acute phase;
Since the aortocoronary bypass surgery; III trimester of pregnancy, during breast-feeding;
Approved chronic heart failure (II-IV functional class NYHA classification);
Coronary artery disease;
Peripheral arterial disease, or cerebrovascular disorders;
Disorders of blood, hemostatic disorders (including hemophilia);
Severe hepatic insufficiency or active liver disease;
Severe renal impairment (creatinine clearance less than 30 mL / min), progressive renal disease; Confirmed by hyperkalemia;
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (formulation contains lactose). Children up to age 15 years.
Dosage
50 mg
Indications
Symptomatic treatment of diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, rheumatic soft tissue, osteoarthritis peripheral joints and spine, including radicular syndrome, tenosynovitis, bursitis) .
The drug relieves or reduces pain and inflammation during the treatment period, with no effect on the progression of the disease.
Pain syndrome weak or moderate severity: neuralgia, myalgia, sciatica, post-traumatic pain, accompanied by inflammation, postoperative pain, headache, migraine, tuberculosis, adnexitis, proctitis, toothache.
Interaction with other drugs
lithium preparations, digoxin: Diclofenac may increase the concentration of lithium and digoxin in the blood plasma. We recommend monitoring the concentration of lithium and digoxin in plasma while the use of diclofenac.
Methotrexate: Care must be taken when assigning diclofenac less than 24 hours before or 24 hours after methotrexate administration, as in such cases can be increased MTX concentration in blood and increases its toxic effects.
Cyclosporin: diclofenac influence on prostaglandin synthesis in the kidneys may enhance cyclosporine nephrotoxicity. Therefore applied dose of diclofenac should be lower than in patients who do not use cyclosporine.
Diuretic and antihypertensive drugs: diclofenac may reduce the hypotensive action of diuretics and antihypertensive agents (e.g., beta-blockers, angiotensin converting enzyme inhibitors – ACE). Patients, especially the elderly, the combination should be administered with caution and regular monitoring of blood pressure. Patients should be adequately hydrated. After the beginning of and periodically during treatment, particularly with concomitant administration of diuretics and ACE inhibitors need to monitor renal function due to increased risk of nephrotoxicity.
Drugs that can induce hyperkalemia: simultaneous application of diclofenac potassium-sparing diuretics, cyclosporine, tacrolimus, or trimethoprim can lead to increased concentration of potassium in blood serum (in the case of a combination of drugs, the indicator should regularly monitor).
Antibacterials – quinolone derivatives: there are anecdotal reports of seizures in patients treated simultaneously quinolone derivatives and diclofenac.
Anticoagulants and antiplatelet agents: caution should be combined with diclofenac formulations of these groups because of the risk of bleeding. Although clinical studies have not been found to influence of diclofenac on the action of anticoagulants, there are isolated reports of an increased risk of bleeding in patients taking this combination of drugs. Therefore, in case of this combination of drugs recommended regular and careful monitoring of patients.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood.
NSAIDs and corticosteroids are: concurrent systemic administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of side effects (in particular from the gastrointestinal tract).
Selective serotonin reuptake inhibitor (SSRI) and the simultaneous application of diclofenac formulations of SSRIs increase the risk of gastrointestinal bleeding.
Hypoglycemic agents: In clinical studies have shown that the combined use of diclofenac does not affect the effectiveness of hypoglycemic drugs. However, the known individual reports on the development in the cases such as hypoglycemia and hyperglycemia, which required changing the dose of hypoglycaemic agents during treatment with diclofenac. Therefore, during the joint application of diclofenac and hypoglycemic drugs recommended for monitoring blood glucose concentrations.
Phenytoin: while applying phenytoin and diclofenac need to monitor the concentration of phenytoin in blood plasma due to the possible increase of its systemic exposure.
Tacrolimus: nephrotoxicity may increase while the use of diclofenac.
Cefamandole, cefoperazone, cefotetan, valproic acid and increase the incidence plicamycin hypoprothrombinemia.
Effect on the synthesis of prostaglandins diclofenac kidney can amplify the toxic effect of gold preparations. The simultaneous use of ethanol, colchicine, corticotropin and drugs St. John’s wort increases the risk of bleeding in the gastrointestinal tract.
Potent inhibitors isoenzyme CYP2C9: caution when coadministered diclofenac and powerful inhibitors isoenzyme CYP2C9 (such as voriconazole) due to a possible increase in diclofenac concentration in the blood serum and amplification of systemic action.
Overdose
Symptoms include nausea, vomiting, epigastric pain, bleeding from the gastrointestinal tract, diarrhea, dizziness, headache, tinnitus, convulsions, decreased blood pressure, respiratory depression, if a large overdose – acute renal failure, hepatotoxicity.
Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at removing arterial hypotension, renal dysfunction, seizures, shock syndrome, respiratory depression. Forced diuresis, hemodialysis ineffective (due to significant bond and intense protein metabolism).
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Nonsteroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. Diclofenac has antiinflammatory, analgesic, antipyretic, and antiplatelet properties. Non-selectively inhibiting cyclooxygenase 1 and 2 (and TSOG1 TSOG2) gives the metabolism of arachidonic acid, reduces the amount of prostaglandins in inflammation. Most effective for pain of inflammatory nature.
In rheumatic diseases inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. When trauma, postoperative diclofenac reduces pain and inflammatory edema.
Pharmacokinetics:
Absorption – rapid and complete, food slows the rate of absorption for 1-4 hours and reduces the maximum concentration (Cmax) is 40%. After oral administration of 50 mg maximum concentration (Cmax) – 1.5 g / ml is achieved through -. 2-3 h plasma concentration is in linear dependence on the magnitude of the dose administered.
Changes in the pharmacokinetics of diclofenac on the background of multiple doses is not marked. Not koumouliruet under recommended dosing interval.
Bioavailability – 50%. Relationship to plasma proteins – more than 99% (most associated with albumin). Penetrates into the synovial fluid; Cmax observed in the synovial fluid for 2-4 hours later than in plasma. The half-life (T1 / 2) from the synovial fluid of 3-6 hours (concentration of the active agent in the synovial fluid after 4-6 h after administration is higher than in the plasma, and remains higher for a further 12 hours). The relationship of drug concentration in synovial fluid from the clinical efficacy of the drug is not clear.
Metabolism: 50% of the active substance is metabolised during the “first pass” through the liver. Metabolism occurs as a result of single or multiple hydroxylation and conjugation with glucuronic acid. The metabolism of the drug is involved isoenzyme CYP2C9. The pharmacological activity of the metabolites is lower than diclofenac.
Systemic clearance is about 260 ± 50 ml / min, the volume of – 550 ml / kg. T1 / 2 from the plasma is on average about 2.5 hours. 65% of the administered dose excreted by the kidneys as metabolites; less than 1% is excreted in unaltered form, the remainder of the dose excreted in bile as metabolites.
In patients with severe renal failure (creatinine clearance (CC) of less than 10 ml / min) increases the excretion of metabolites in the bile, thus increasing their concentration in the blood is not observed.
In patients with chronic hepatitis or compensated cirrhosis pharmacokinetic parameters of diclofenac are not changed.
Diclofenac passes into breast milk.
Pregnancy and breast-feeding
Insufficient data about the safety of diclofenac in pregnant women. Therefore assign diclofenac in I and II trimesters of pregnancy should be only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac, like other inhibitors of prostaglandin synthesis, is contraindicated in the last 3 months of pregnancy (may suppress the contractility of the uterus and premature closure of the ductus arteriosus in the fetus).
Diclofenac enters the small quantities in breast milk. To prevent the adverse effect on the child, the preparation should not be administered to nursing women. If necessary, the drug should stop breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
Criteria for evaluation of the incidence of side reactions very often (> 1/10), often (> 1/100
special instructions
To reduce the risk of occurrence of undesired phenomena of drug should be used in the lowest effective dose for the shortest period necessary to alleviate symptoms. NSAID therapy, including diclofenac, particularly long-term treatment and therapy with the use of high doses may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipoproteinemia, diabetes mellitus, and smoking) treatment with drugs containing diclofenac, should be started only after a thorough examination and analysis.
Due to the importance of prostaglandins in maintaining renal blood flow should be particularly careful when assigning patients to the drug with cardiac or renal insufficiency, hypertension, elderly patients, patients taking diuretics or other drugs that affect renal function and patients who have at whatever reason, decrease in blood volume is observed (eg after extensive surgery). If in such cases, prescribe diclofenac, is recommended as a precautionary measure to monitor renal function. After the cessation of drug therapy is usually marked by normalization of renal function prior to the initial values.
When diclofenac observed such phenomena as bleeding or ulceration / perforation of the gastrointestinal tract, in some cases, fatal. These events can occur at any time when using the drug in patients with or without previous symptoms and serious gastrointestinal diseases in history, or without them. Elderly patients these complications can have serious consequences. With the development in patients receiving diclofenac, bleeding or ulceration of the gastrointestinal tract drug should be discontinued.
To reduce the risk of toxic effect on the gastrointestinal tract, the drug should be used in the lowest effective dose for the shortest possible time, especially with respect to patients with ulcerative lesions of the gastrointestinal tract, especially complicated by bleeding or perforation in history, as well as elderly patients. Patients with an increased risk of gastrointestinal complications, and treated with low-dose acetylsalicylic acid or other drugs that can increase the risk of gastro-intestinal tract, should be taken gastroprotectives. Patients with lesions of the gastrointestinal tract in history, especially the elderly, should be reported to your doctor about all symptoms of the digestive system.
During long-term therapy is necessary to monitor liver function, peripheral blood picture, analysis of fecal occult blood. With prolonged use of diclofenac can be marked increase in the activity of one or more “liver” enzymes. When storing and advancing impaired liver function or liver disease symptoms occurs or other symptoms (e.g., eosinophilia, rash, and so on.) To cancel the drug. It should be borne in mind that hepatitis during treatment with diclofenac may occur without prodromal phenomena. Caution should be taken when applying diclofenac in patients with hepatic porphyria, since the drug may provoke porphyria attacks.
Diclofenac can reversibly inhibit platelet aggregation, however in patients with hemostatic disturbances with prolonged use is necessary to carefully control the respective laboratory parameters.
In patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including with nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with allergic symptoms rinitopodobnymi), and patients with an allergy to other drugs (rash, pruritus, urticaria) be particularly careful in the appointment of diclofenac (ready to resuscitation).
When diclofenac is very rare reports of severe, in some cases fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. The greatest risk and incidence of severe dermatological reactions occurred within the first month of treatment with diclofenac. With the development in patients receiving the drug, the first signs of skin rash, mucosal lesions or other signs of hypersensitivity, diclofenac should be discontinued. Anti-inflammatory effects of NSAIDs, including diclofenac, can complicate diagnosis of infectious processes.
Due to the adverse effect on fertility, women planning pregnancy, drug is not recommended. At infertile patients (including undergoing examination) it is recommended to cancel the drug.
Patients who during treatment with diclofenac having visual disturbances, dizziness, drowsiness or other disorders of the central nervous system, you should not drive vehicles and use machines.
Storage conditions
In a dry, dark place at a temperature from 15 to 25 ° C.
Keep out of the reach of children!
Dosing and Administration
All patients receiving diclofenac should apply it in the lowest effective dose for the shortest time required for reducing the severity of symptoms.
The inside is not liquid, during or after a meal, drinking plenty of water. Adults and adolescents from 15 years – 50 mg 2-3 times a day. Upon reaching the optimal therapeutic effect dose was gradually reduced to supportive treatment in a dose of 50 mg / day. The maximum daily dose – 150 mg.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

STADA

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